Chronic Rhinosinusitis: Biochemical Markers and Biofilm

The investigators will conduct a descriptive, prospective, three-armed study concerning the pathophysiology of chronic rhinosinusitis.

In one part of the study the investigators want to investigate the presence of biofilm in patients with chronic rhinosinusitis both with and without nasal polyps compared with a control group of subjects without chronic rhinosinusitis. The investigators will also compare quality of life in the three groups and correlate disease severity in biofilm patients versus patients where biofilm was not present.

The hypothesis here is that biofilm patients suffers a more severe disease.

In the other arm of the study the investigators will compare the presence of different biochemical compounds in the three study groups. The investigators specifically want to investigate matrix metalloproteases and apoptosis-inhibitors with immunohistochemistry. The investigators may also add other compounds to our test-battery if interesting candidates surface in the literature during the inclusion period.

The purpose of this part of the study is to investigate candidates for the development of nasal polyposis.

The investigators plan to include 100 patients suffering from chronic rhinosinusitis with nasal polyps, and 100 patients with chronic rhinosinusitis without nasal polyps and 30 control subjects.

Study Overview

• Status: Unknown
• Conditions: Chronic Rhinosinusitis
• Intervention / Treatment: Procedure: biopsy

• Study Type: Observational
• Enrollment (Anticipated): 230

Contacts and Locations

• Study Contact: Name: Kjell-Arild Danielsen, MD; Phone Number: +47 93402150; Email: Kjell.Arild.Danielsen@ahus.no

Study Locations

• Norway
  • Akershus
    • Lørenskog, Akershus, Norway, 1478
      • Recruiting
      • AHUS
      • Contact: Erik S Lie, MD; Phone Number: +47 90687197; Email: Erik.S.Lie@ahus.no
      • Principal Investigator: Kjell-Arild Danielsen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to sinonasal surgery at Ahus, Norway

Description

Inclusion Criteria:

• Diagnosis of chronic rhinosinusitis based on EPOS3
• Submitted to surgery
• Using nasal corticosteroids

Exclusion Criteria:

• Age below 18 years
• Using antibiotics at the time of surgery
• Using systemic corticosteroids
• Sempers triad

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group	Procedure: biopsy; One or more biopsies from nasal mucosa will be harvested during surgery
chronic rhinosinusitis with nasal polyps	Procedure: biopsy; One or more biopsies from nasal mucosa will be harvested during surgery
chronic rhinosinusitis without nasal polyps	Procedure: biopsy; One or more biopsies from nasal mucosa will be harvested during surgery

Collaborators and Investigators

• Sponsor: University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: March 10, 2010
• First Posted (Estimate): March 11, 2010

Study Record Updates

• Last Update Posted (Estimate): July 7, 2011
• Last Update Submitted That Met QC Criteria: July 6, 2011
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: 2009/1720(REK)